MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Catalog Number	1110200210
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cynosure lutronic technology (clt) clinical team contacted the site to investigate the event.Clt clinical confirmed no injuries had occurred.Parameters used were within published guidelines, including icd at 10/10/10.Device evaluation was not performed since spark and soot observation is a known occurrence.Cryogen is applied to the treatment site during vascular treatment to precool the skin.The cryogen begins to vaporize from the surface of the skin shortly after contact.The laser fires onto the surface of the skin after a delay time.The spark/ignition events occur when residual cryogen vapors remaining on the skin surface interact with the high-energy 1064 nm laser fluence.Longer pre-cooling and delay times increase the likelihood of uneven vapor accumulation, thereby elevating the risk of ignition.This can be observed as a spark and can result in topical burn.To reduce the probability of reoccurrence the treatment provider was informed that vascular lesion treatments over 60 j/cm2 should utilize an icd setting of 10/10/10 per the recent update.A customer letter has since gone out to notify customers of this recommended setting update.Implementation of the updated recommended settings is intended to reduce the likelihood of reoccurrence; however, the spark and soot condition has not been fully eliminated and continues to occur.As such, the event continues to be assessed and reported as a device malfunction.The event is reportable per fda medical device reporting title 21 cfr part 803 since an observed malfunction occurred and could likely cause or contribute to a serious injury if the malfunction were to recur.
Event or Problem Description
It was reported that spark and soot occurred during a leg vessel treatment using clarity ii.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 5 carlisle road; westford, MA 01886
• MDR Report Key: 25437847
• Report Number: 3021199089-2026-00039
• Device Sequence Number: 16042087
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)250220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 1110200210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female